Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster

K193581 · Sri Trang Gloves (Thailand) Public Company Limited · LZA · Mar 20, 2020 · General Hospital

Device Facts

• Record ID: K193581
• Device Name: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
• Applicant: Sri Trang Gloves (Thailand) Public Company Limited
• Product Code: LZA · General Hospital
• Decision Date: Mar 20, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Device provides a physical barrier; tested for permeation resistance against various chemotherapy drugs and fentanyl citrate per ASTM D6978. Used in clinical settings; operated by healthcare professionals. Output is the physical barrier protection provided during patient examination. Benefits include reduced risk of exposure to patient contaminants and hazardous chemotherapy agents.

Clinical Evidence

Bench testing only. No clinical data. Performance demonstrated via ASTM standards: D6319 (physical dimensions, tensile strength, elongation), D5151 (freedom from holes), D6124 (powder residue), and D6978 (chemotherapy drug permeation). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Nitrile examination gloves; powder-free. Dimensions, tensile strength, and elongation meet ASTM D6319-10. Biocompatibility confirmed via ISO 10993 series. Permeation resistance tested per ASTM D6978. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs and fentanyl. Contraindicated for use with Carmustine and Thiotepa.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs (K182241)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in a clear, sans-serif font. The FDA logo is a recognizable symbol of the agency's mission to protect and promote public health.

March 20, 2020

Sri Trang Gloves (Thailand) Public Company Limited % Jordan Smith Quality Assurance and Regulatory Affairs Leader Sri Trang USA, Inc. 5820 West Cypress Street, Suite H Tampa, Florida 33607-1785

#### Re: K193581

Trade/Device Name: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove

Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: November 27, 2019 Received: December 23, 2019

Dear Jordan Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K193581

#### Device Name

Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster

#### Indications for Use (Describe)

This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The tested chemotherapy drugs and permeation times are as follows:

Bleomycin Sulfate 15 mg/mL, >240 minutes Busulfan 6 mg/mL. >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL. >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes

Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine 1 mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL, >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 27.9 minutes Trisenox 1 mg/mL , >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes

Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL. >240 minutes

WARNING: Not for use with Carmustine or Thiotepa.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) Summary

# K193581

## [As Required by 21 section 807.92 (c)]

Summary prepared: March 17, 2020

## A. APPLICANT INFORMATION

Submitter Name: Sri Trang Gloves (Thailand) Public Company Limited Address: 10 Soi 10 Phetkasem Rd. Hatyai Songkhla. Thailand 90110 Phone: [phone] Fax: [phone] Contact Person: Mr. Anan Pruksanusak, Managing Director

## B. US AGENT & CONTACT PERSON INFORMATION

Official Correspondent: Sri Trang USA, Inc. Address: 5820 West Cypress Street, Suite Tampa, Florida 33607-1785 Phone: [phone] Fax: [phone] Contact person: Mr. M. Jordan Smith, Quality Assurance and Regulatory Affairs Leader

## C. DEVICE IDENTIFICATION

Device Trade or Proprietary Name: Non-Sterile. Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster

Device Common or Usual Name: Examination glove

Device Classification Name: Nitrile Patient Examination Glove (21 CFR 880.6250)

Device Product Codes: LZA, LZC, QDO

Device Class: Class I

#### D.PREDICATE DEVICE INFORMATION

510(k) Number: K182241

Trade Name: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs

Common Name: Examination Glove

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Classification Name: Nitrile Patient Examination Glove Device Product Codes: LZA, LZC, QDO Device Class: Class I Regulation Number: 21 CFR 880.6250

# E. DESCRIPTION OF THE DEVICE

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs and Fentanyl.

## F. INTENDED USE OF THE DEVICE

This device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

## G. Technological Characteristics Comparison Table

| TECHNOLOGICAL<br>CHARACTERISTICS | STANDARD | PREDICATE DEVICE<br>K182241 | SUBJECT DEVICE<br>K193581 | COMPARISON |
|----------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | | K182241 | K193581 | |
| Trade Name | | Non-sterile, Powder-Free<br>Nitrile Examination<br>Glove Black Tested for<br>use with Chemotherapy<br>Drugs | Non-sterile, Powder Free<br>Nitrile Examination<br>Gloves | Different |
| Common Name | | Examination Glove | Examination Glove | Identical |
| Classification Name | | Nitrile Patient<br>Examination Glove | Nitrile Patient<br>Examination Glove | Identical |
| Device Product Codes | | LZA, LZC, QDO | LZA, LZC, QDO | Identical |
| Device Class | | Class I | Class I | Identical |
| Regulation Number | | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Indications for Use | N/A | This device is a<br>disposable device<br>intended for medical<br>purpose that is worn on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. The tested<br>chemotherapy drugs are<br>as follows: Carmustine<br>(BCNU) Cisplatin,<br>Cyclophosphamide,<br>Dacarbzine (DTIC),<br>Doxorubicin<br>Hydrochloride,<br>Etoposide (Toposar), | This device is a<br>disposable device<br>intended for medical<br>purpose that is worn on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner.<br>Bleomycin Sulfate,<br>15mg/mL, >240 minutes<br>Ifosfamide 50 mg/mL,<br>>240 minutes<br>Busulfan 6mg/mL, >240<br>minutes<br>Irinotecan 20 mg/mL | Similar |

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| | >240 minutes |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Carboplatin (Paraplatin) 10 mg/mL, >240 minutes |
| | Mechlorethamine 1mg/mL, >240 minutes |
| | Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes, 22.8 minutes, and 22.3 minutesminutes |
| | Melphalan 5 mg/mL, >240 minutes |
| | Cisplatin 1.0 mg/mL, >240 minutes |
| | Methotrexate 25 mg/mL, >240 minutes |
| | Cyclophosphamide (Cytoxan) 20 mg/mL, |
| Fluorouracil,<br>Methotrexate, Paclitaxel (Taxol), Thiotepa,<br>Vincristine Sulfate<br><br>Note Carmustine (BCNU) and Thiotepa have low permeation times<br><br>Fentanyl tested as follows: Fentanyl Citrate | >240 minutes<br><br>Mitomycin C 0.5 mg/mL, >240 minutes<br><br>Cytarabine 100 mg/mL, >240 minutes<br><br>Mitoxantrone 2 mg/mL, >240 minutes<br><br>Dacarbazine (DTIC) 10 mg/mL, >240 minutes<br><br>Paclitaxel (Taxol) 6 mg/mL, >240 minutes<br><br>Daunorubicin 5 mg/mL, >240 minutes<br><br>Rituximab 10 mg/mL, >240 minutes<br><br>Docetazel 10 mg/mL, >240 minutes<br><br>Thiotepa 10 mg/mL, 27.9 minutes<br><br>Doxorubicin Hydrochloride 2 mg/mL, >240 minutes<br><br>Trisenox mg/mL, >240 minutes<br><br>Epirubicin (Ellence) 1 mg/mL, >240 minutes<br><br>Vincristine Sulfate 1 mg/mL, >240 minutes<br><br>Etoposide (Toposar) 20 mg/mL, >240 minutes<br><br>Fludarabine 25 mg/mL, >240 minutes<br><br>Fluorouracil 50 mg/mL, >240 minutes<br><br>Gemcitabine 38 mg/mL, >240 minutes<br><br>Idarubicin 1 mg/mL, >240 minutes<br><br>WARNING – Not for use with Carmustine and Thiotepa<br><br>Fentanyl tested as follows:<br>Fentanyl Citrate 100 |

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| | | | mcg/2mL, >240 minutes | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimensions: overall<br>length | ASTM D 6319-10,<br>Minimum 230 mm | 238 mm | 238 mm (NOF_SL) | Similar |
| | | 238 mm | 240 mm (NOF_EL) | |
| | | 238 mm | 240 mm (NOF_SD) | |
| Dimensions: width | ASTM D 6319-10,<br>110 ± 10 mm | Size Large | Size Large | Similar |
| | | 114 mm | 110 mm | |
| | | 115 mm | 110 mm | |
| | | 114 mm | 111 mm | |
| Dimensions: palm and<br>finger thickness | ASTM D 6319-10,<br>Minimum 0.05 mm | Palm | Palm | Similar |
| | | 0.07 mm | 0.05mm (NOF_SL) | |
| | | 0.07 mm | 0.05mm (NOF_EL) | |
| | | 0.07 mm | 0.10 mm (NOF_SD) | |
| | | Finger | Finger | |
| | | 0.07 mm | 0.08 mm (NOF_SL) | |
| | | 0.08 mm | 0.08 mm (NOF_EL) | |
| | | 0.09 mm | 0.14 mm (NOF_SD) | |
| Tensile strength: before<br>and after aging | ASTM D 6319-10 | Before<br>35 MPa | Before<br>34 MPa (NOF_SL) | Similar |
| | | 33 MPa | 37 MPa (NOF_EL) | |
| | | 35 MPa | 33 MPa (NOF_SD) | |
| | | After<br>31 MPa | After<br>38 MPa (NOF_SL) | |
| | | 32 MPa | 41 MPa (NOF_EL) | |
| | | 34 MPa | 37 MPa (NOF_SD) | |
| Ultimate elongation:<br>before and after aging | ASTM D 6319-10 | Before<br>538% | Before<br>570 (NOF_SL) | Similar |
| | | 534% | 564% (NOF_EL) | |
| | | 535% | 630% (NOF_SD) | |
| | | After<br>518% | After<br>535% (NOF_SL) | |
| | | 493% | 551% (NOF_EL) | |
| | | 503% | 625% (NOF_SD) | |
| Powder Free Residue | ASTM D 6319-10 | 0.7 mg/glove | 0.3 mg/glove (NOF_SL) | Similar |
| | | 0.8 mg/glove | 0.5 mg/glove (NOF_EL) | |
| | | 0.8 mg/glove | 0.5 mg/glove (NOF_SD) | |
| Biocompatibility | ISO 10993-10<br>Primary Skin<br>Irritation in Rabbits | Under the conditions of<br>the study, the polar and<br>non- polar device<br>extracts were found not<br>to be an irritant to the<br>animal model. | Under the conditions of<br>the study, the polar and<br>non-polar device extracts<br>were found not to be an<br>irritant to the animal<br>model. | Same |
| | ISO 10993-5<br>In vitro cytotoxicity | Cytotoxic | Cytotoxic | Same |
| ISO 10993-11<br>Tests for systemic<br>toxicity | the device extracts did<br>not elicit a systemic<br>response in the animal<br>model. | the device extracts did<br>not elicit a systemic<br>response in the animal<br>model. | Same | |
| ISO 10993-10<br>Guinea Pig<br>Sensitization | Under the conditions of<br>the study, the polar and<br>non- polar device<br>extracts were found not<br>to be sensitizers to the<br>animal model. | Under the conditions of<br>the study, the polar and<br>non-polar device extracts<br>were found not to be<br>sensitizers to the animal<br>model. | Same | |

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## H. Summary of Non-Clinical Performance Testings

Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:

| Measurement | Standard Criteria | Subject Device Model | Results | |
|-------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------|
| Before aging | 14 MPa Min | Tensile strength per ASTM D 6319-10 | | |
| | | Model - NOF_SD Orchid | 33 | |
| | | Model - NOF_SL Lilac | 34 | |
| | | Model - NOF_EL Oyster | 37 | |
| After aging (70C, 168hrs.) | 14 MPa Min | Model - NOF_SD Orchid | 37 | |
| | | Model - NOF_SL Lilac | 38 | |
| | | Model - NOF_EL Oyster | 41 | |
| Before aging | 500% Min | Ultimate elongation per ASTM D 6319-10 | | |
| | | Model - NOF_SD Orchid | 630 | |
| | | Model - NOF_SL Lilac | 570 | |
| | | Model - NOF_EL Oyster | 564 | |
| After aging (70C, 168hrs.) | 400% Min | Model - NOF_SD Orchid | 625 | |
| | | Model - NOF_SL Lilac | 535 | |
| | | Model - NOF_EL Oyster | 551 | |
| Length (mm) | 230 mm Min (M) | Model - NOF_SD Orchid | 240 mm | |
| | | Model - NOF_SL Lilac | 238 mm | |
| | | Model - NOF_EL Oyster | 240 mm | |
| Thickness(mm) Single<br>wall Finger | 0.05 mm Min | Model - NOF_SD Orchid | 0.14 | |
| | | Model - NOF_SL Lilac | 0.08 | |
| | | Model - NOF_EL Oyster | 0.08 | |
| Thickness (mm) Single<br>wall Palm | 0.05 mm Min | Model - NOF_SD Orchid | 0.10 | |
| | | Model - NOF_SL Lilac | 0.06 | |
| | | Model - NOF_EL Oyster | 0.05 | |
| Width | 110+/-10 mm (M) | Model - NOF_SD Orchid | 111 | |
| | | Model - NOF_SL Lilac | 110 | |
| | | Model - NOF_EL Oyster | 110 | |
| | | Freedom from holes per ASTM D5151-2006 | | |
| Freedom from holes | GI, AQL 2.5 | Model - NOF_SD Orchid: 125 | 0 | |
| | Accept - 7 | Model - NOF_SL Lilac: 125 | 1 | |
| | Reject - 8 | Model - NOF_EL Oyster: 125 | 1 | |
| | | Powder Residue, ASTM D6124-2006 | | |
| Powder Residue | 2.0 mg/glove | Model - NOF_SD Orchid | 0.5 mg/glove | |
| | | Model - NOF_SL Lilac | 0.3 mg/glove | |
| | | Model - NOF_EL Oyster | 0.5 mg/glove | |
| | | Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978 | | |
| Test Drug and<br>Concentration | Minimum Breakthrough<br>Detection Time Model –<br>NOF_SD Orchid | Minimum Breakthrough<br>Detection Time Model –<br>NOF_SL Lilac | Minimum Breakthrough<br>Detection Time Model –<br>NOF_EL Oyster | Steady State<br>Perm. Rate |
| Bleomycin<br>Sulfate<br>15,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Busulfan<br>6,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carboplatin<br>10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carmustine<br>(BCNU)<br>3,300 ppm | 17.1 minutes | 22.8 minutes | 22.3 minutes | 0.4<br>0.4<br>0.3 |
| Cisplatin<br>1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytoxan<br>20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytarabine<br>100,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| DTIC<br>10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Daunorubicin<br>2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Docetaxel<br>10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Doxorubicin<br>hydrochloride<br>2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Epirubicin<br>2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Etoposide<br>(Toposar)<br>20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fludarabine<br>25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fluorouracil<br>50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Gemcitabine<br>38,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Idarubicin<br>1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Ifosfamide<br>50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Irinotecan<br>20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mechlorethamine<br>1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Melphalan<br>5,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Methotrexate<br>25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitomycin C<br>500 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitoxantrone<br>2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| | | | | |
| Taxol<br>6,000 ppm | No breakthrough up to<br>240 minutes | No breakthrough up to 240<br>minutes | No breakthrough up to<br>240 minutes | N/A |
| Rituximab<br>10,000 ppm | No breakthrough<br>up to 240 minutes | No breakthrough<br>up to 240 minutes | No breakthrough<br>up to 240 minutes | N/A |
| Thiotepa 10,000<br>ppm | 27.9 minutes | 39.1 minutes | 39 minutes | 0.3<br>0.3<br>0.2 |
| Trisenox<br>1,000 ppm | No breakthrough up to<br>240 minutes | No breakthrough up to 240<br>minutes | No breakthrough up to<br>240 minutes | N/A |
| Vincristine<br>fulfate 1,000 ppm | No breakthrough up to<br>240 minutes | No breakthrough up to 240<br>minutes | No breakthrough up to<br>240 minutes | N/A |
| Fentanyl Citrate<br>100 mcg/2mL | No breakthrough up to<br>240 minutes | No breakthrough up to 240<br>minutes | No breakthrough up to<br>240 minutes | N/A |

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The test results demonstrated that the proposed device complies with following standards:

ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves

ASTM D6124-2006 (Reapproved 2001) Standard Test Method for Residual Powder on Medical Gloves

ASTM D6978 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

ASTM D412-2006a (reapproved 2013) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension

ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven

ASTM D3767-03 Standard Practice for Rubber-Measurement of Dimensions

ISO 2859 Sampling Procedures and Tables for Inspection by Attributes

- · Tested according to ASTM D5151 for pinholes and freedom from holes, Inspection Level: GI, AQL = 2.5
- · Tested according to ASTM D6124 for powder residue, Inspection Level: N =5, AQL = N/A
- · Tested according to ASTM D412 for tensile strength and ultimate elongation before and after aging, Inspection Level: S-2, AQL 4.0
- · Tested according to ASTM D3767 for length, thickness, and width, Inspection Level: S-2. AOL 4.0

ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo cytotoxicity Minimal Essential Media Elution Test:

ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and delayedtype hypersensitivity

ISO 10993-11 Biological evaluation of medical devices-Part 11 Tests for systemic toxicity Acute Systemic Toxicity Test.

## I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that Non-Sterile. Powder Free Nitrile

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Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs – Oyster are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182241.